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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00195455 |
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Date of registration:
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12/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study Evaluating Estradiol/Trimegestone in Vasomotor Symptoms (VMS) in Post-Menopausal Women.
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Scientific title:
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A Prospective Open Label Study to Evaluate Vasomotor Symptoms Control and Bleeding Patterns With a Continuous Regimen of a New Progestin Trimegestone 0.125 mg and 17 b Estradiol 1 mg (Totelle),as HT on Postmenopausal Women |
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Date of first enrolment:
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February 2005 |
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Target sample size:
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133 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00195455 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Mexico, gomezlj@wyeth.com |
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Generally healthy postmenopausal women 45 to 55 years of age inclusive, with at least
1 year of natural occurring amenorrhea, with vasomotor symptoms, with at least 4 hot
flushes per day
- Intact uterus
Exclusion Criteria:
- Known or suspected breast carcinoma or estrogen-dependent neoplasm
- Undiagnosed abnormal genital bleeding
Age minimum:
45 Years
Age maximum:
55 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Postmenopause
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Intervention(s)
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Drug: 17b Estradiol
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Drug: Trimegestone
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Primary Outcome(s)
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To assess vasomotor symptoms control with a continuous regimen of 17 b estradiol 1mg and Trimegestone (TMG) 0.125 mg.
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Secondary Outcome(s)
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Evaluate changes in the Menopause-Specific Quality of Life Questionnaire
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Study bleeding patterns throughout the treatment period (6 months)
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Secondary ID(s)
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0753T-101538
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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